A Comparison of Hydrogel Dressings and Ocular Lubricants in the Prevention on Corneal Damage in the Critically Ill

This study has been completed.
Sponsor:
Information provided by:
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT00513734
First received: August 8, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted

August 8, 2007
August 8, 2007
September 2004
Not Provided
Development of clinically significant corneal exposure [ Time Frame: throughout length of admission to ITU ]
Same as current
No Changes Posted
Not Provided
Not Provided
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A Comparison of Hydrogel Dressings and Ocular Lubricants in the Prevention on Corneal Damage in the Critically Ill
Randomised Trial Comparing the Efficacy of Ocular Lubricant (Lacrilube) and Polyacrylamide Hydrogel Dressing (Geliperm) for the Prevention of Exposure Keratopathy in the Critically Ill

Corneal damage in critically ill patients is common. There are currently two popular methods of treatment in the UK; hydrogel dressings and lubricating ointment. We propose to randomise patients to have a different treatment for each eye and see which one is more effective.

Microbial keratitis, particularly pseudomonas-related, has been widely reported amongst Intensive therapy unit (ITU) patients and the need for effective eye care in ITU has been recognised for some time. We compare two popular methods of eye care; a hydrogel dressing and lacrilube ointment. Each recruited patient had each eye randomised to different treatments. Daily ophthalmology ward rounds were undertaken to identify any corneal exposure keratopathy. Patients were removed from the trial if one eye developed significant exposure needing treatment.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Keratitis
  • Other: Hydrogel dressing
    3x3cm hydrogel dressing over closed eye
  • Other: Lacrilube ointment
    lubricant put into eye (inferior formix)
  • Active Comparator: 1
    Geliperm Hydrogel Dressing
    Intervention: Other: Hydrogel dressing
  • Active Comparator: 2
    Lacrilube ointment
    Intervention: Other: Lacrilube ointment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2005
Not Provided

Inclusion Criteria:

  • All patients admitted to Intensive care and expected to stay for more than 2 days

Exclusion Criteria:

  • Primary orbital injury
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00513734
003171
Yes
Not Provided
Barts & The London NHS Trust
Not Provided
Study Director: Marie Healy, FRCA Lead Clinicain, Dept. of Intensive Care Medicine, Royal London Hospital, London E1 1BB
Barts & The London NHS Trust
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP